The tablet combines two female hormones, estrogen and progestin, and is meant to deliver doses four times during its 28-day treatment cycle, the FDA said in a news release.

The drug was evaluated by more than 1,800 women during clinical testing in North America and Europe. The most common adverse effects were irregular bleeding, breast tenderness, headache, nausea and vomiting, weight gain and acne.

Women who smoke while taking the drug are at greater risk of serious cardiovascular problems. Women older than 35 who smoke should not use the product, the agency warned.

Bayer is based in Wayne, N.J.

More information

The FDA has more about this approval.

-- Scott Roberts